Osteoporosis Trial, Recruiting NCT04796350 Sponsor: AgNovos Healthcare, LLC Condition: Osteoporosis
Back to Osteoporosis

Osteoporosis Trial, Recruiting

NCT04796350
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The person is a woman who has gone through menopause, has not had a period for at least one year, and is between 65 and 91 years old.
  • The person has had a hip fracture caused by a minor incident (such as a low-level fall) and is scheduled to have surgery to repair that hip.
  • The person has at least one additional factor that raises the risk of a future hip fracture, such as: being assessed as moderate or high risk for falls; having fallen two or more times in the past year; having a history of vertigo, dizziness, or low blood pressure when standing; having a bone density scan result showing significant bone loss at the hip; taking more than three prescription medications daily; having vision problems (such as difficulty seeing, loss of depth perception, vision in only one eye, macular degeneration, or cataracts); having had a previous fracture in a bone other than the hip; having mild memory or thinking difficulties or delirium; having Parkinson's disease at stage 3 or 4; or having a 10-year hip fracture risk score above 15% based on a standard fracture risk calculation tool.
  • The person is expected to be able to walk — even with the help of a walking aid — after the hip repair surgery, beyond just basic movements like getting in and out of a chair.
  • Informed consent has been provided by the person themselves, or by a legally authorised representative on their behalf — and if a representative provides consent, the person must still be able to understand and follow the post-surgery requirements.
  • The person's willingness and ability to attend all study visits and follow-up appointments for the full length of the study has been documented.

Who may not be able to join:

  • The person is currently taking part in another clinical trial that involves the hip being treated in this study.
  • The person has previously had hip surgery or a hip fracture on the opposite hip to the one that is fractured now.
  • The person has additional new fractures (beyond the current hip fracture) that, in the treating doctor's opinion, would interfere with recovery or rehabilitation.
  • The person has an infection, broken skin, or an open wound near the area of the body where the study treatment would be applied.
  • The person has had a gradually worsening, unexplained pain in the opposite hip over the past three months that the doctor thinks may indicate an underlying bone or joint problem on that side.
  • Imaging scans show significant bone or joint problems in the hip, including signs that may suggest a particular type of unusual fracture, or the person has already been diagnosed or treated for that type of fracture.
  • The person has a bone disease other than osteoporosis, such as Paget's disease, a bone condition related to kidney disease, or a softening of the bones condition.
  • The person currently has active cancer.
  • The person has very severe kidney disease, defined by a specific kidney function measurement falling below a certain level (confirm with trial site).
  • The person has moderate or severe difficulties with memory or thinking, as measured by a standard short test.
  • The person has a known allergy to calcium-based materials used to fill bone.
  • In the doctor's judgement, the person is not a suitable candidate for the study — for example, due to significant mental health concerns, active alcohol or drug misuse, or because the person's current overall health would not support an elective orthopaedic surgical procedure.
  • The person does not meet specific eligibility checks carried out before or during surgery, as outlined in the study plan (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 240-753-6421

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
AgNovos Healthcare, LLC
Registry
ClinicalTrials.gov
Start date
24 April 2021
Est. completion
1 April 2027

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇪🇸 Spain 🇬🇧 United Kingdom

Primary endpoints

Cumulative incidence of secondary fragility hip fractures; Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov